The development of nuclear medicine, in particular in the field of diagnosis by positron emission tomography (PET), makes it necessary to review the usual methods for producing, packaging and handling radiopharmaceutical substances intended for administration to patients.
Radiopharmaceutical substances are chemical compounds labeled with radioactive isotopes, intended for medical use. Problems of existing methods and equipment are mainly due to the increase in the use of isotopes whose radiation energy is relatively high, and to the fact that a higher level of automation is required due to the short half-life of said isotopes.
Dose fractionation systems are available on the market. They make it possible to dilute a base radiopharmaceutical product, to prepare the dilute solution in vials and to place these vials in a radiation shielding device for transportation. The vials are then delivered to the nuclear medicine departments of hospitals. Such devices are mainly used by radiopharmaceutical production companies.
Currently the doses are prepared either in “multi-dose” vials, such as penicillin crimped cap vials out of which the medical staff draws with a syringe the desired amount for a single patient (especially in Europe), or directly loaded as single doses and shipped in syringes (especially in the U.S.A.).
Problems related to the current art practice are described in U.S. Patent Application Publication No. US 2004/0084340 A1 (PCT No. PCT/BE02/00050). This document describes a device to be used in the automated preparation, packaging and further handling of an individual dose of a radiopharmaceutical compound, comprising the following set of elements (see FIGS. 1A, 1B and 1C):                a cartridge 1 intended to contain said individual dose, provided at a first end with a closing element 2 and at a second end with a component serving as a piston 3;        a radiation-shielding container 10 comprising an inner cylinder-like part 4 capable to enclose the sealed cartridge 1, and an outer cylinder-like part 5, serving as an additional shielding for transportation. The outer part, provided with a shielding lid 6, is capable to enclose the inner part;        a plunger 7 to be fitted to the cartridge 1 at the time of an injection, while said cartridge is still inside said inner cylinder-like part 4 of the radiation shielding container 10, provided with a sliding rod capable to contact and move, i.e. push or pull said piston 3 of the cartridge 1.        
An injection means can be fitted to the first end of the cartridge at the time of an injection, while the cartridge is still inside said inner cylinder-like part of the radiation shielding container. The closing element 2 is a septum, such as an elastomeric stopper and the injection means is capable to pierce this septum in a sterile manner and thus to enter in contact with the radiopharmaceutical compound.